Injection device, system, and method for use

ABSTRACT

An injection device for the self-administration of an injection of solution that includes a body portion/handle configured for engagement with a cartridge containing the solution and an injection needle. The injection device includes a safety mechanism whereby ejection of solution from the injection device cannot be done unless the safety mechanism is released. The injection device further involves two-stage deployment whereby a needle may be inserted upon release of the safety mechanism and solution is injected upon full insertion of the needle.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. ProvisionalApplication No. 62/960,538, filed on Jan. 13, 2020. The presentapplication is also related to U.S. patent application Ser. No.15/815,026 entitled Self-Administered Injection Device and Method, filedon Nov. 16, 2017; U.S. Provisional Application 62/422,686 entitledSystems and Methods for Self-Administration of Botulinum Toxin, filed onNov. 16, 2016; and U.S. Provisional Application No. 62/532,052 entitledSystems and Methods for Self-Administration of Botulinum Toxin, filed onJul. 13, 2017, the contents of which are incorporated by referenceherein in their entireties.

FIELD OF THE INVENTION

The present application relates to a method and system forself-administration of an injectable substance such as botulinum toxin,vaccinations, in vitro fertilization medicines, chronic illnesstreatment medicines, flu shots, insulin, or other medicinal or cosmetictreatment substances. More particularly, the present application relatesto a method and system for self-administration of an injectablesubstance at or around the facial area. Still more particularly, thepresent application relates to a method and system forself-administration of an injectable substance at or near the eye andforehead area.

BACKGROUND OF THE INVENTION

The background description provided herein is for the purpose ofgenerally presenting the context of the disclosure. Work of thepresently named inventors, to the extent it is described in thisbackground section, as well as aspects of the description that may nototherwise qualify as prior art at the time of filing, are neitherexpressly nor impliedly admitted as prior art against the presentdisclosure.

In many contexts, injections of medicine are performed by trainedprofessionals. For example, vaccinations, flu shots, antibiotics, andother medicines are commonly administered by nurses, physicianassistants, doctors, or other trained professionals. In some cases,where injection of medicine is performed on a regular or relativelyfrequent periodic basis, patients may learn to administer injections ontheir own. For example, individuals with diabetes may learn to regularlyadminister insulin to control blood sugar levels in their system. Theseindividuals may also regularly test their blood sugar levels todetermine whether there is a need for an injection. Other examplesinclude patients with chronic illnesses such as multiple sclerosis, forexample. In these contexts, the patient may become relatively wellversed in and comfortable with the injection process due to therepetition of the procedure. In general, the precise location of theinjection is not important for these purposes.

Botulinum toxin is a substance used for various purposes, including bothmedical and cosmetic purposes. Medical uses may include treating medicalconditions such as hyperhidrosis and migraine headaches. In somecosmetic applications, botulinum toxin is used to relax muscles, such asfacial muscles, in order to reduce the appearance and/or the formationof lines or wrinkles in the skin or otherwise smooth the appearance ofskin, for example around an individual's eyes, forehead, mouth, neck,scalp, or other areas of the face or body.

Botulinum toxin, which may be provided under the brand name BOTOX,DYSPORT, XEOMIN, or other names, is typically applied by injection. Asyringe is filled with a desired amount of the botulinum toxin andinjected into a muscle or other tissue. Generally, botulinum toxininjected for medical or cosmetic purposes is injected by a medicalprofessional, such as a physician or a nurse or aesthetician practicingunder the guidance of a physician. This is, in part, because thelocation of the administration is important with respect to theaesthetic effect of the injection. Still further, the amount of theinjected substance also affects the resulting cosmetic result. Moreover,these types of injections are not commonly performed on a frequent basisand, as such, the patient does not have the opportunity to becomecomfortable with the process.

BRIEF SUMMARY OF THE INVENTION

The following presents a simplified summary of one or more embodimentsof the present disclosure in order to provide a basic understanding ofsuch embodiments. This summary is not an extensive overview of allcontemplated embodiments, and is intended to neither identify key orcritical elements of all embodiments, nor delineate the scope of any orall embodiments.

The present application relates to a method and system forself-administration of an injectable substance or solution such asbotulinum toxin, vaccinations, in vitro fertilization medicines, chronicillness treatment medicines, flu shots, insulin, or other medicinal orcosmetic treatment substances. More particularly, the presentapplication relates to a method and system for self-administration of aninjectable substance at or around the facial area. Still moreparticularly, the present application relates to a method and system forself-administration of an injectable substance at or near the eye andforehead area.

In one embodiment, the present disclosure relates to an injection devicefor the self-administration of an injection of solution that includes abody portion/handle configured for engagement with a cartridgecontaining the solution and an injection needle. The injection deviceincludes a safety mechanism whereby ejection of solution from theinjection device cannot be done unless the safety mechanism is released.The injection device further involves two-stage deployment whereby aneedle may be inserted upon release of the safety mechanism and solutionis injected upon full insertion of the needle.

In one embodiment an injection device for injection of a solution isprovided. The injection device includes a body portion and a cartridgeremovably couplable to the body portion. The body portion includes acartridge end and a handle end and comprises a main body, an injectionassembly, and actuation button, and a safety assembly. The injectionassembly extends through the main body to the cartridge end and effectsinsertion of a needle and ejection of the solution. Actuation of theactuation button leads to insertion of the needle and dispensing of thesolution. The safety mechanism being configured to prevent insertion ofthe needle and/or dispensing of the solution. The cartridge comprises asyringe assembly, the needle, and a needle shield over the needle. Thesyringe assembly includes a drug chamber and a piston, wherein the drugchamber houses the solution. The safety mechanism is released upondepression of the needle shield such that the needle may be inserted andthe solution dispensed.

In some embodiments, the injection device has multi stage deploymentcomprising insertion of the needle and injection of the solution and themulti stage deployment may be activated by actuating the actuationbutton. The injection assembly may work with the piston of the cartridgeto dispense the solution. The body portion may further comprise acocking assembly comprising a cocking handle, an end cap, a cockingring, and a snap ring. The cocking assembly is provided at the handleend of the body portion. The cartridge may further comprise a safetyassembly including a safety interlock wherein when the safety interlockis in a used configuration, the needle shield is locked in a forwardposition and the cartridge cannot be reused. The injection assembly mayfurther comprise a needle insertion spring and a drug delivery spring.The cartridge may include an extension piece and the body portion mayinclude an opening piece, wherein the extension piece is received by theopening piece to removably couple the cartridge to the body portion. Thecartridge may be predosed with a specific quantity of solution.

In another embodiment, an injection device for injection of a solutionis provided. The injection device includes a body portion and acartridge removably couplable to the body portion. The body portion maycomprise an injection assembly and a safety mechanism. The injectionassembly effects insertion of a needle and ejection of the solution. Thesafety mechanism being configured to prevent insertion of a needleand/or dispensing of a solution. The cartridge may comprise a syringeassembly, a safety mechanism, a needle, and a needle shield positionedover the needle. The syringe assembly may include a drug chamber and apiston, wherein the drug chamber houses the solution. The safetymechanism may be released upon proper positioning of the injectiondevice, wherein such release enables the needle to be inserted and thesolution to be dispensed. Proper positioning may be indicated bydepression of the needle shield.

In some embodiments, the body portion may further comprise an actuationbutton, wherein actuation of the actuation button leads to insertion ofthe needle and dispensing of the solution. In some embodiments, theactuation button cannot be actuated until the safety mechanism isreleased. The drug chamber may be formed of glass and other portions ofthe cartridge may be formed of plastic. The injection device may havemulti stage deployment comprising insertion of the needle and injectionof the solution. The multi stage deployment is triggered by actuation ofthe actuation button.

In yet another embodiment, an injection kit for injection of a solutionis provided. The injection kit may comprise an injection device, astaging tray, and an injection template. The injection device maycomprise a body portion and a cartridge, the cartridge being removablycouplable to the body portion. The body portion may have a cartridge endand a handle end and may comprise an injection assembly, a safetymechanism, and an actuation button. The safety mechanism may beconfigured to prevent insertion of a needle and/or dispensing of asolution. Actuation of the actuation button may lead to insertion of theneedle and dispensing of the solution. The cartridge includes a syringeassembly, a needle, and a needle shield. The syringe assembly includes adrug chamber and a piston, wherein the drug chamber houses the solution.The safety mechanism is released upon depression of the needle shieldsuch that the needle may be inserted and the solution dispensed. Thestaging tray includes positions for receiving one or more cartridges.The injection template has holes for receiving the needle.

In some embodiments, the positions on the staging tray correspond withinjection locations on a body and wherein the cartridges are preloadedon the tray. Further, the injection template may correspond with alocation on a body and the holes align with injection sites at thatlocation. The injection kit may include a numbing agent.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, thevarious embodiments of the present disclosure are capable ofmodifications in various obvious aspects, all without departing from thespirit and scope of the present disclosure. Accordingly, the drawingsand detailed description are to be regarded as illustrative in natureand not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the subject matter that is regarded as formingthe various embodiments of the present disclosure, it is believed thatthe invention will be better understood from the following descriptiontaken in conjunction with the accompanying Figures, in which:

FIG. 1 illustrates a front view of a user's forehead, showingapproximate locations for botulinum toxin injections, according to oneor more embodiments.

FIG. 2 illustrates a side view of a user's eye area, showing approximatelocations for botulinum toxin injections, according to one or moreembodiments.

FIG. 3 illustrates a perspective view of a kit including an injectiondevice, a staging tray, and a plurality of cartridges, according to oneor more embodiments.

FIG. 4a illustrates an injection device, in accordance with oneembodiment.

FIG. 4b illustrates an injection device, in accordance with oneembodiment.

FIG. 5a illustrates the injection device with the cartridge disengagedfrom the body portion, in accordance with one embodiment.

FIG. 5b illustrates the injection device with the cartridge disengagedfrom the body portion, in accordance with one embodiment.

FIG. 6 illustrates an end view of the plate of the body portion, inaccordance with one embodiment.

FIG. 7a illustrates a cross sectional view of the outer housing of thecartridge 204, in accordance with one embodiment.

FIG. 7b illustrates an end view of the outer housing of the cartridge,in accordance with one embodiment.

FIG. 8 illustrates an exploded view of the body portion of the injectiondevice, in accordance with one embodiment.

FIG. 9 illustrates an exploded view of the cartridge of the injectiondevice, in accordance with one embodiment.

FIG. 10a the outer housing of the cartridge, in accordance with oneembodiment.

FIG. 10b the outer housing of the cartridge, in accordance with oneembodiment.

FIG. 11a illustrates the exterior of the body portion/handle in thecocked position, in accordance with one embodiment.

FIG. 11b illustrates the interior of the body portion/handle of FIG. 11aalong Section F-F.

FIG. 12a illustrates the exterior of body portion/handle in the firedposition, in accordance with one embodiment.

FIG. 12b illustrates the interior of the body portion/handle of FIG. 12aalong Section G-G.

FIG. 13a illustrates the exterior of a fresh cartridge before fixationon a body portion/handle and before use, in accordance with oneembodiment.

FIG. 13b illustrates the interior of the cartridge of FIG. 13a alongSection A-A.

FIG. 14a illustrates the exterior of a fresh cartridge as fixed to thebody portion/handle with the needle shield depressed, in accordance withone embodiment.

FIG. 14b illustrates the interior of the cartridge of FIG. 14a alongSection B-B.

FIG. 15a illustrates the exterior a cartridge as fixed to the bodyportion/handle with the needle inserted and the drug dispensed, inaccordance with one embodiment.

FIG. 15b illustrates the interior of the cartridge of FIG. 15a 204 alongSection C-C.

FIG. 16a illustrates the exterior of a spent cartridge, with the drugdispensed and the needle shield locked in a forward position, inaccordance with one embodiment.

FIG. 16b illustrates the interior of the cartridge of FIG. 16a alongSection D-D.

FIG. 17a illustrates an exterior of an injection device with the bodyportion/handle cocked and a fresh cartridge attached, in accordance withone embodiment.

FIG. 17b illustrates the interior of the injection device of FIG. 17aalong Section J-J.

FIG. 18a illustrates the exterior of an injection device with the bodyportion/handle cocked and a fresh cartridge attached with the needleshield depressed, in accordance with one embodiment.

FIG. 18b illustrates the interior of the injection device of FIG. 18aalong Section K-K.

FIG. 19a illustrates the exterior of an injection device with the bodyportion/handle fired and a cartridge attached with the drug dispensed,in accordance with one embodiment.

FIG. 19b illustrates the interior of the injection device of FIG. 19aalong Section L-L.

FIG. 20a illustrates the exterior of an injection device with the bodyportion/handle fired and a cartridge attached with the drug dispensedand the needle shield locked forward, in accordance with one embodiment.

FIG. 20b illustrates the interior of the injection device of FIG. 20aalong Section M-M.

FIG. 21 illustrates a top view of a staging tray holding a plurality ofcartridges, in accordance with one embodiment.

FIG. 22 illustrates a front view of an injection patch, in accordancewith one embodiment.

FIG. 23 illustrates a front view of an injection patch, in accordancewith one embodiment.

FIG. 24 illustrates a front view of an injection patch arranged on auser's forehead, according to one or more embodiments.

FIG. 25 illustrates a front view of an injection patch arranged on auser's eye area, according to one or more embodiments.

FIG. 26 illustrates a perspective view of an injection patch 300arranged on a user's forehead and an injection patch 400 arranged on auser's eye area, according to one or more embodiments.

DETAILED DESCRIPTION

The present application relates to a method and system forself-administration of an injectable substance such as insulin,botulinum toxin, chronic illness treatment medicines, flu shots, orother medicinal or cosmetic treatment substances. More particularly, thepresent application relates to a method and system forself-administration of an injectable substance at or around the facialarea. Still more particularly, the present application relates to amethod and system for self-administration of an injectable substance ator near the eye and forehead area.

The present disclosure relates to systems and methods forself-administration or administration to others of injections. It is tobe appreciated that the systems, methods, devices, and kits disclosedherein facilitate injection of any substance by any user. In variousembodiments these injections may be botulinum toxin injections,vaccinations, and medications. The systems and methods facilitate userinjection of an injectable substance at specific and precise locationson the body. Particularly, the present disclosure, in one or moreembodiments, relates to an injection device, a kit including theinjection device and other accoutrements, and a method for using theinjection device and/or kit. The injection device may be particularlyadapted for use by a relatively untrained user and may provide for easyloading of pre-filled cartridges and safety mechanisms associated withexposing a needle and injecting a substance. In general, the injectiondevice may use single use prefilled cartridges.

It is to be appreciated that while the systems and methods disclosedherein are specifically described with respect to self-administration ofinjections, the systems and methods may alternatively be used by a userto administer injections to another person. Thus, while the systems andmethods are especially useful for self-administration, they are in noway limited to self-administration.

The kit may include a series of cartridges each containing a particularquantity of injectable substance (such as botulinum toxin), theinjection device, a staging tray for arranging the cartridges beforeuse, and one or more, such as a series of, injection patches. Componentsincluded in the kit may further the ability for a user toself-administer, or to administer to others, a solution without trainingor frequent use. In particular, the cartridges in the kit may havesecluded or hidden needles for purposes of safety, but also forobstructing view of the needle for users uncomfortable with needles. Thecartridges may be preloaded/dosed cartridges such that dosing is simpleand straight forward. The cartridges and the injection device may worktogether for a simple reloading process and the staging tray may allowfor arrangement of the cartridges in an area and/or order for ease ofuse. Finally, the injection patches/template may work with the injectiondevice to help position the injection device prior to injection and thetemplate may include a numbing agent to reduce pain or injectionsensation. The injection patches or template may have openings ormarkings through which the needle is inserted.

Accordingly, the injection device and/or kit may be used toself-administer botulinum toxin injections efficiently with ease, lowanxiety, low pain, high precision (dosage and location), and highaccuracy (dosage and location). It is to be appreciated that while muchof the present disclosure is focused on botulinum toxin injections,other injections may be performed with some or all of the devicesdescribed herein. For example, the injection device and/or kit mayalternatively be used to self-administer vaccinations, medications (suchas in vitro fertilization medications), and other.

Referring now to FIGS. 1 and 2, the present application, in one or moreembodiments, relates to a device, kit, and/or method forself-administration of botulinum toxin injections. FIGS. 1 and 2illustrate locations where a user may wish to self-inject botulinumtoxin. FIG. 1 illustrates a front view of a user's forehead, showingapproximate locations 10 for botulinum toxin injections, according toone or more embodiments. FIG. 2 illustrates a side view of a user's eyearea, showing approximate locations 10 for botulinum toxin injections,according to one or more embodiments. A user may wish to injectbotulinum toxin near the user's eye(s), forehead, neck, scalp, and/orany other suitable location. In other embodiments, other locations maybe suitable for injection and/or other substances may be injected usingthe devices and/or kits described herein. The precise spacing ofinjection points may vary person-to-person based on the size of theinjection area for that person.

FIG. 3 illustrates a perspective view of a kit including an injectiondevice, a staging tray, and a plurality of cartridges, according to oneembodiment. As shown, the kit 100 may include an injection device 102, aseries of cartridges 104, and a staging template or tray 106. The kitmay further include a series of injection patches or templates, anumbing agent, and/or other useful components.

Injection Device

Embodiments an injection device 202 and cartridge 204 are shown in FIGS.4a -10 b.

FIGS. 4a and 4b illustrate an injection device 202, in accordance withone embodiment. As shown, the injection device 202 may include acartridge 204 and a body portion or handle 208. The cartridge 204 may beremovable from the body portion 208. The body portion 208 may have anactuation button 210 or other component configured to both extend aneedle from the device 202 and dispense a solution from the device 202.This may alternatively be referred to as insertion of a needle into theuser and injection of the solution into the user.

A safety mechanism or assembly, described more fully below, may preventinjection unless/until proper positioning and/or pressure are applied tothe injection device. Upon proper positioning and pressure, theinjection device may be configured to insert a needle from within thecartridge into a user and, upon full insertion of the needle, inject thesolution stored in the cartridge into the user. The cartridge may thenbe removed from the body portion 208, preparing the body portion 208 forengagement with another cartridge.

The injection device 202 may have a multi stage deployment. Actuation ofthe actuation button leads to insertion of the needle. Upon completeinsertion of the needle, the solution may be injected. In variousembodiments, the solution comprises a medication such as botulinumtoxin. While deployment is two stage, activation is may be achieved by asingle user action, for example, depression of actuation button 210. Inalternative embodiments, two stage user activation may be employed.Further, in some embodiments, a safety mechanism is released prior toinsertion of the needle.

More particularly, in one embodiment, an actuation button will not workuntil a needle shield is fully depressed, for example by pushing theneedle shield against a patient's skin at an injection site.De-activation of the actuation button may be done in any suitablemanner. In one embodiment, the actuation button may not be actuateduntil the needle shield is fully depressed. In another embodiment, theactuation button may not trigger insertion of the needle until theneedle shield is fully depressed. Once the needle shield is fullydepressed, the actuation button may be pressed and a two stage injectionoccurs. The first is insertion of the needle, for example via a springforce. The second stage, which occurs upon full insertion of the needle,is injection of a solution through the needle.

The body portion 208 of the injection device may be configured and/orsized for a comfortable fit in a human hand and, as such, may be sized,shaped, or molded in the general form of a baton, stick, handle, orother relatively comfortable shape for grasping by the human hand. Inone or more embodiments, the body portion 208 may generally have anelongated pen-like length and size. In one embodiment, the body portion208 may have a generally circular cross sectional shape. In otherembodiments, the body portion 208 may have any suitable cross section.The body portion 208 may include one or more ergonomic features.

FIGS. 5a and 5b illustrate the injection device 202 with the cartridge204 disengaged from the body portion 208, in accordance with oneembodiment. The cartridge 204 includes an extension piece 203 havingengagement nubs 205. The body portion 208 has a plate 207. The plate 207includes an opening piece 214 for receiving and axially aligning withthe extension piece 203. The opening piece 214 has a track 211 for theengagement nubs 205 to follow. Bumpers 213 may be provided on the plate207 of the body portion 208 and/or on the cartridge 204 to reducetolerance variation of the engagement of the body portion 208 with thecartridge 204. While a specific engagement of the cartridge 204 with thebody portion 208 is described, it is to be appreciated that othermanners of engaging the cartridge 204 with the body portion 208 mayalternatively be used consistent with the teachings herein.

In the embodiment shown, to assemble the injection device 202, theextension piece 203 of the cartridge 204 is inserted into the openingpiece 214 of the body portion 208. The cartridge 204 and/or body portion208 are rotated, for example with a ¼ turn rotation, to latch thecylinder 204 to the body portion 208. This may be referred to as ¼ turnattachment and removal and may be enabled with high pitch threading ofthe track 211. Other amounts of rotation may alternatively be used.Bayonet lugs may be provided on a main body 230 of the injection device202 (see FIG. 8) to lock the main body 230 in place. In alternativeembodiments, other engagement mechanisms between the cartridge 204 andthe body portion 208, such as a snap fit, may be used.

FIG. 6 illustrates an end view of the plate 207 of the body portion 208,in accordance with one embodiment. FIG. 6 shows the opening piece 214with the track 211 for receiving the engagement nubs of the cartridge.FIG. 6 also illustrates the bumpers 213. In the embodiment shown, threebumpers are provided. In other embodiments, more or fewer bumpers,including no bumpers, may be provided.

FIG. 8 illustrates an exploded view of the body portion 208 of theinjection device 202, in accordance with one embodiment. In otherembodiments, some of body portion 208 may vary from the embodimentshown. As shown, the body portion 208 may include a main body 230, acocking assembly 232, and an injection assembly 241.

The main body 230 extends between a handle end 231 and a cartridge end233. The actuation button 210 is provided on main body 230 through aslot 217. The actuation button 210 is received by a notch 249 of a mainshaft 247 of the injection assembly 241, described below.

The cocking assembly 232 is provided at the handle end 231 of theinjection device. The cocking assembly comprises a cocking handle 234,an end cap 236, a cocking spring 238, and a snap ring 240. As assembled,the cocking assembly sits over and in end portion 235 of main body 230.These components engage one another to enable a user to pull back on thecocking handle 234 and put the injection device 202 in a cocked positionfor firing, described with respect to FIGS. 11a and 11 b.

The injection assembly 241 extends through the main body 230 to thecartridge end 233 and effects insertion of the needle and ejection ofthe medication. The injection assembly 241 includes a needle insertionspring 242, a delivery button 244, a drug delivery spring 246, a mainshaft 247, the opening piece 214, and the plate 207. The delivery button244 is received by a notch 251 on the main shaft 247. The injectionassembly 241 further includes a safety interlock 250. When engaged, thesafety interlock 250 prevents the actuation button 210 and deliverybutton 244 from being released from notches 249 and 251 of the mainshaft 247, respectively. Other forms of safety interlock mayalternatively be used.

FIG. 9 illustrates an exploded view of the cartridge 204 of theinjection device 202, in accordance with one embodiment. The cartridge204 may be a single use prefilled cartridge. In general, the cartridgemay be formed from any suitable material(s). In some embodiments, thecartridge is formed plastic, cyclic olefin polymer, glass, or othermaterials. In some embodiments, the cartridge may comprise a pluralityof materials. In other embodiments, at least the solution contactinginterior portion of the cartridge may be formed from glass or othermaterial having limited or no reactivity with the to be containedsolution, in order to increase shelf life of the solution stored in thecartridge. Such glass may comprise pyrex, tempered glass, or other. Insome embodiments, the interior of the cartridge thus may comprise glassor other non-reactive material and such interior may be encased with amoldable or formable material such as plastic, wherein the moldablematerial is shaped as illustrated in the figures.

The cartridge 204 may include a syringe assembly 260, a safety assembly252, and an outer housing 270.

In the embodiment shown, the syringe assembly 260 includes a plunger261, a syringe 262 having fins 263 and a needle 265, an o-ring 264, asyringe holder 266, roll pins 267, and a spring 268. The roll pins 267are retained in the syringe holder 266. A drug chamber (see FIGS. 13aand 13b ) is provided within the syringe 262. In some embodiments, thedrug chamber may be formed of a different material than the rest of thecartridge. For example, the drug chamber may be formed from a generallynon-reactive material such as glass or cyclic olefin polymer, and otherportions of the cartridge may be formed of a moldable or formablematerial such as plastic.

The drug chamber may be configured for holding an injectable fluid,drug, solution, or substance for dispensing from the injection device.The plunger 261 is positioned to poise the solution for injection. Thedrug chamber may be fluid communication with the needle 265. The plunger261 may be configured to move through the drug chamber when engaged bythe main shaft of the body portion/handle so as to cause the solution inthe drug chamber to be dispensed from the drug chamber through theneedle 265. It is to be appreciated that different needle lengths may beused for different injection sites or treatments. In some embodiments,the needle may have a length of between about 5 mm and about 10 mm andan insertion length of between about 3 mm and about 6 mm. In oneembodiment, the needle has a length of 7.89 mm and an insertion lengthof 4 mm. In general, any suitable length, insertion length, or diameterof needle may be used.

In some embodiments, the injection device 202 may have an insertionlength or needle depth setting or component. For example, the respectivedevice may have a threaded component arranged on an end through whichthe needle may extend. The threaded component may be turned in onedirection to lengthen the body of the injection device or cartridge, andin another direction to shorten the body of the injection device orcartridge. In this way, the threaded component may be configured tocontrol a length of needle that extends from the injection device duringan injection. Thus, the depth of the injection may be at least partiallycontrolled by use of the threaded component. In other embodiments, theneedle depth component may lengthen and shorten using different means,other than threading. In some embodiments, the needle depth component orsetting may be adjustable by a user. In other embodiments, the needledepth component or setting may be a permanent or semi-permanentadjustment or setting, which may be preconfigured prior to the user'sreceipt of the kit. In some embodiments, a permanent, semi-permanent, ortemporary needle depth setting may be configured such that a needle mayextend no more than ⅛^(th) of an inch beyond the injection device, forexample. In other embodiments, the needle depth setting may beconfigured for a longer or shorter needle depth. For example, for usewith vaccinations or other intramuscular administration, the needle orinjection depth may be on the order or 1 to 1.5 inches.

The safety assembly 252 may include a safety interlock 254 having pins259, a slip ring 256 having notches 257 and posts 255, and a needleshield 258. The needle shield secludes the needle unless or until it ispressed against the skin. The needle shield includes an opening to allowthe needle to extend therethrough to penetrate the skin. When thecartridge is pressed against the skin, the needle may approach the endof the opening or it may stay stationary until the main shaft advancesthe needle into the skin.

FIG. 7a illustrates a cross section of the outer housing 270 of thecartridge 204, in accordance with one embodiment. FIG. 7b illustrates anend view of the outer housing of the cartridge 204, in accordance withone embodiment. FIGS. 10a and 10b illustrate alternative views of theouter housing of FIGS. 7a and 7b . As shown, the outer housing 270includes tracks 272 on an interior surface for receiving the slip ring256 of the safety assembly 252. Once the unit is activated, fins 263 ofthe syringe 262 rotate the slip ring 256. The slip ring 256 travels downthe tracks 272 and is then locked forward and is unable to rest to aninitial position. This locks the needle shield 258 forward so thecartridge 204 cannot be used a second time. Accordingly, a safetyinterlock wherein when the safety interlock is in a used configuration,the needle shield is locked in a forward position and the cartridgecannot be reused

Use

In one embodiment, to use the injection device and inject the solutionor medication, a user cocks the body portion/handle 208, attaches acartridge 204 to the body portion/handle 208, positions the injectiondevice 202, and presses the actuation button 210.

FIGS. 11a-12b illustrate the body portion/handle 208 in the positionsthrough which it moves during use of the injection device. FIGS. 13a-16billustrate the cartridge 204 in the positions through which it movesduring use of the injection device. FIGS. 17a-20b illustrate theinjection device 202, including the body portion/handle 208 and thecartridge 204, in the positions through which it moves during use.

FIGS. 11a and 11b illustrate the body portion/handle 208 in the cockedposition. FIG. 11a illustrates the exterior of the body portion/handle208 as a user would perceive it. FIG. 11b illustrates a cross sectionalview along Section F-F of FIG. 11a . This thus illustrates the interiorof the body portion/handle 208 along Section F-F. It is to beappreciated that the position shown, the cocked position, is theposition in which the body portion/handle 208 is arranged for receipt ofa cartridge.

In one embodiment, in order to cock the body portion/handle 208, theuser pulls back the cocking handle 234, causing the insertion spring 242to compress behind the main shaft 247. In this position, the actuationbutton 210 has not been depressed and the needle insertion spring 242 isin a coiled position. Similarly, the delivery button 244 has not beenactuated and the drug delivery spring 246 is in a coiled position. Theactuation button 210 is engaged with notch 249 and the delivery button244 is engaged with notch 251. The actuation button 210 maintains themain shaft 247 back and in an undeployed position. The safety interlock250 is engaged and prevents the actuation button 210 and delivery button244 from being released.

FIGS. 12a and 12b illustrate the body portion/handle 208 in the firedposition. FIG. 12a illustrates the exterior of the body portion/handle208 as a user would perceive it. FIG. 12b illustrates the interior ofthe body portion/handle 208 along Section G-G of FIG. 12a . It is to beappreciated that the position shown, the fired position, is the positionin which the body portion/handle 208 is arranged after medication hasbeen dispensed from the device.

In one embodiment, in order to fire the injection device, the userpresses the actuation button 210. This releases the actuation button 210from the notch 249 in the main shaft 247, releasing the injectionbutton's hold on the main shaft 247. Pressing of the actuation button210 from the main shaft 247 will nevertheless not result in firing ofthe device unless the safety interlock 250 is disengaged. This is donewhen a cartridge is fixed to the body portion/handle 208 and pressedagainst a surface, such as the skin of a user, to depress the needleshield of the cartridge. Assuming the safety interlock 250 isdisengaged, release of the main shaft 247 inserts the needle into thepatient via delivery button 244. At the full travel of main shaft 247and delivery button 244, the second stage occurs. The final linearmovement causes the ramp 253 inside housing 230 to actuate the deliverybutton 244 and release the delivery button 244 from the notch 251 whichwill then inject the solution into the patient (shaft 247 pushes onplunger 261).

Accordingly, in this position, the actuation button 210 has beendepressed and the needle insertion spring 242 is in a released position.Similarly, the delivery button 244 has been actuated and the drugdelivery spring 246 is in a released position. The actuation button 210is disengaged from notch 249 and the delivery button 244 is disengagedfrom notch 251.

FIGS. 13a and 13b illustrate a fresh cartridge 204 before fixation on abody portion/handle and before use. FIG. 13a illustrates the exterior ofthe cartridge 204 as a user would perceive it. FIG. 13b illustrates theinterior of the cartridge 204 along Section A-A of FIG. 13 a.

In an unused and unfixed position, the syringe 262 is in the syringeholder 266 and set back from a needle end of the syringe holder 266. theplunger 261 is engaged with the syringe 262 but is not pressing fluid inthe drug chamber 269. The needle shield 258 extends over and away fromthe needle 265. Movement of the plunger 261 and needle 265 iseffectuated by the main shaft 247 of the body portion/handle (see, forexample, FIG. 8).

FIGS. 14a and 14b illustrate a fresh cartridge 204, as it would presentwhen fixed to the body portion/handle, and with the needle shielddepressed. FIG. 14a illustrates the exterior of the cartridge 204 as auser would perceive it. FIG. 14b illustrates a cross section of thecartridge 204 along Section B-B of FIG. 14a , thus illustrating theinterior of the cartridge. It is to be appreciated that in the positionshown, the cartridge 204 will have released the safety mechanism on thebody portion/handle. In general, the needle shield 258 is depressed(thereby releasing the safety mechanism) when the injection device ispressed against the skin by a user. In some embodiments, the force usedto depress the needle shield may range from about 0.5 pounds to about4.5 pounds. In one embodiment, the force used to depress the needleshield is less than about 1 pound.

As shown, the needle shield 258 is depressed. This causes the needleshield 258 to engage the safety interlock 254 of the cartridge 204 andpress back pins 259. The pins 259 in turn press on the safety interlock250 of the body portion/handle 208. While this releases the safetymechanism of the body portion/handle 208, the needle 265 remains in theretracted position with syringe 268 set back in the syringe holder 266and the needle shield 258 extending over the needle 265 until the userpresses actuation button 210. The plunger 261 is engaged with thesyringe 262 but still is not pressing fluid in the drug chamber 269.

FIGS. 15a and 15b illustrate a cartridge 204, as it would present whenfixed to the body portion/handle with the needle inserted and the drugdispensed. FIG. 15a illustrates the exterior of the cartridge 204 as auser would perceive it. FIG. 15b illustrates a cross section of thecartridge 204 along Section C-C of FIG. 15a , thus illustrating aninterior of the cartridge 204. It is to be appreciated that in theposition shown, the cartridge 204 is pressed against a user and theneedle is inserted into the user.

As shown, the needle shield 258 is depressed and positionedsubstantially as in the position of FIGS. 14a and 14b . In the positionof FIGS. 15a and 15b , however the plunger 261 is engaged with thesyringe 262 and has pushed the syringe 268 forward in the syringe holder266 to force the needle 265 out of the outer housing 270 and into aninsertion position. In one embodiment, the main shaft 247 pushes theback end of the syringe to insert the needle 265 into the patient. Oncethe second stage occurs and the delivery button 244 is released, themain shaft 247 pushes the plunger 261 to inject the pharmaceuticals. Insome embodiments, the needle 265 extends from the cartridge an insertionlength of between about 3 mm and about 6 mm. Movement of the plunger 261further acts to force fluid from the drug chamber 269 through the needle265. In some embodiments, the needle 265 may extend from the outerhousing at a distance of between about 2 mm and about 6 mm. It is to beappreciated that the extension of the needle 265 from the housing, orthe injection length or insertion depth, may vary and may depend on whatis being injected where.

FIGS. 16a and 16b illustrate a spent cartridge 204, with the drugdispensed and the needle shield 258 locked in a forward position. FIG.16a illustrates the exterior of the cartridge 204 as a user wouldperceive it. FIG. 16b illustrates a cross-section of cartridge 204 alongSection D-D of FIG. 16a , thereby illustrating the interior of thecartridge 204. It is to be appreciated that in the position shown, thecartridge 204 has been lifted from the user and the needle removed fromthe user.

After injection of the solution or medication, a user lifts theinjection device from their skin. Lifting the injection device pulls theneedle from the user and releases the force being put on the needleshield 258. The needle shield 258 thus returns to its initial position,shown in FIGS. 13a and 13b , and is locked in place. Initially, theposts 259 of the slip ring 256 of the safety assembly 252 of thecartridge 204 can go back and forth in the tracks 272 of the outerhousing 270. The notches 257 of the slip ring 256 receive the fins 263of the syringe 262. The fins 263 rotate the slip ring 256. Once theactuation button 210 is pressed, the fins 263 of the syringe 260 movethe posts 259 laterally in the track 272. Once this happens, the needleshield 258 is pushed forward and locked into place.

Upon return of the needle shield 258 to its initial position, the pins259 pull away from the safety interlock 250 of the body portion/handle208 and the safety mechanism is reengaged. Notwithstanding return of theneedle shield 258 to its initial position, the needle 265 remains in aninsertion position—extending from the outer housing but now covered bythe needle shield 258.

FIGS. 17a and 17b illustrate the injection device 202 with the bodyportion/handle 208 cocked and a fresh cartridge 204 attached. FIG. 17athus combines FIG. 11a (cocked body portion/handle 208) and FIG. 13a(fresh cartridge) and FIG. 17b combines FIGS. 11b and 13b . FIG. 17aillustrates the exterior of the injection device 202 as a user wouldperceive it. FIG. 17b illustrates the interior of the injection device202 along Section J-J of FIG. 17 a.

FIGS. 18a and 18b illustrate the injection device 202 with the bodyportion/handle 208 cocked and a fresh cartridge 204 attached with theneedle shield 258 depressed. FIG. 18a thus combines FIG. 11a (cockedbody portion/handle 208) and FIG. 14a (fresh cartridge with needleshield depressed) and FIG. 18b combines FIGS. 11b and 14b . FIG. 18aillustrates the exterior of the injection device 202 as a user wouldperceive it. FIG. 18b illustrates the interior of the injection device202 along Section K-K of FIG. 18 a.

FIGS. 19a and 19b illustrate the injection device 202 with the bodyportion/handle 208 fired and a cartridge 204 attached with the drugdispensed. FIG. 19a thus combines FIG. 12a (fired body portion/handle208) and FIG. 15a (cartridge with needle inserted and drug dispensed)and FIG. 19b combines FIGS. 12b and 15b . FIG. 19a illustrates theexterior of the injection device 202 as a user would perceive it. FIG.19b illustrates the interior of the injection device 202 along SectionL-L of FIG. 19 a.

FIGS. 20a and 20b illustrate the injection device 202 with the bodyportion/handle 208 fired and a cartridge 204 attached with the drugdispensed and the needle shield locked forward. FIG. 20a thus combinesFIG. 12a (fired body portion/handle 208) and FIG. 16a (spent cartridgewith needle shield locked forward) and FIG. 20b combines FIGS. 12b and16b . FIG. 20a illustrates the exterior of the injection device 202 as auser would perceive it. FIG. 20b illustrates the interior of theinjection device 202 along Section M-M of FIG. 20 a.

The user thus starts with a body portion/handle. The user fixes a freshcartridge to the body portion/handle by rotating the cartridge onto thebody portion/handle. The user cocks the injection device by pulling backon the cocking handle. The user presses the needle shield of thecartridge against their skin, thereby releasing the safety mechanism.With the safety mechanism released, the user is able to press theactuation button, which releases the main shaft of the bodyportion/handle. The main shaft deploys the plunger of the cartridge, theneedle is extended, and the medication is released. In some embodiments,pressing the needle shield against their skin may comprise aiming theinjection device towards a template and pressing the injection deviceonto the template in a position such that the needle shield ispositioned substantially above a marker for where injection shouldoccur.

In the embodiment described, the safety mechanism is released bydepressing the needle shield. Typically, this may occur when the userpresses the tip of the cartridge against their skin just prior toinjection. Broadly speaking, as the user presses the tip of thecartridge against their skin, the cartridge may engages the bodyportion/handle and trigger an internal mechanical or electrical switch,which allows the injection component to function. In one or moreembodiments, for example, the internal switch may include a chamfered,beveled, or cam surface that causes a blocking element to cause theinjection component, or main shaft, to become live. Other types ofmechanical switches may also or alternatively be used such as switchesthat block trigger motion rather than the injection component motion.Still other approaches may also be used. Electrical switches may be usedwhere the intruding cartridge creates or interrupts an electricalcontact, which allows the injection component to become live. Stillother approaches using electrical switches may be used. Moreover, thesafety mechanism may be provided in any suitable location. For example,the safety mechanism may be provided entirely on the cartridge whereactivation of the injection component on the body portion is simply notstrong enough to overcome the resistance of the safety component on thecartridge. Other approaches and locations of the safety component mayalternatively be used.

In one or more embodiments, injection is generally achieved bycooperation of a main shaft of the body portion/handle and a plunger ofthe cartridge. The main shaft may be driven by a spring, biasingmechanism, or other advancing mechanism. The main shaft 247 and deliverybutton 244 push in the needle. Once delivery button 244 is released, themain shaft 247 pushes on plunger 261 to inject the solution,pharmaceutical, or medication. The needle depth may be defined by thedepth at which the injection is to take place. For botulinum toxininjections, the depth may be relatively shallow, while other injections,including intramuscular injections such as vaccines, may call for deeperneedle penetration. The cartridge and/or injection device may becalibrated or designed to accommodate any suitable needle penetration.

Staging Template/Tray

As discussed with respect to FIG. 3, a staging tray or template 106 maybe provided. The staging tray 106 may be configured to hold thecartridges 104/204 in a position and/or arrangement for engagement bythe injection device. The staging tray 106 may come preloaded withcartridges in a sterilized, sealed package. In other embodiments, thestaging template may be separate from the cartridges and the cartridgesmay be placed in the staging template by the user.

FIG. 21 is a top view of a staging tray holding a plurality ofcartridges, in accordance with one embodiment. In some embodiments, thestaging tray 206 may be arranged so as to correspond with the generalarrangement and order of injections. For example, as shown, the stagingtray 206 may include a horseshoe or upside down U shape correspondinggenerally to the locations of injections extending upward/downward alongthe side of a left eye, across the top of the forehead, andupward/downward along the side of right eye. That is, as shown, the fourleft cartridges 204 may be used to perform four injections along theleft eye. The five cartridges 204 arranged along the top may be used toperform injections across the forehead. The four right cartridges 204may be used to perform four injections along the right eye. In one ormore embodiments, the cartridges 204 arranged in the tray 206 may havevarying doses depending on the location of the corresponding injection.As such, the template 206 may be preloaded with the cartridges to assureproper doses are used in appropriate locations. In general, the tray maybe configured to generally correspond with any injection location on thebody and roughly indicate where an injection should be done on the body.Alternatively, in some embodiments, the tray may not have locationscorresponding with injection locations. For example, the tray may havespaces to hold cartridges wherein the spaces indicate the volume ofsolution in the cartridge.

In one or more embodiments, the staging tray 206 shown in FIG. 21 may beassembled by the user. For example, while the cartridges may bepreloaded into the tray, the tray may be shipped in a plurality of partsas defined by the dividing lines. The tray may be assembled by the userby place the tray on a relatively surface and placing the piecesadjacent to each other as shown. In some embodiments, the tray mayinclude hook and loop, adhesive, or other fastening mechanisms to securethe several parts of the tray together.

Patch/Injection Template

FIGS. 22 and 23 illustrate front views of injection patches, inaccordance with one embodiment. The injection patches may be adapted forparticular placement on the body and may include injection locationsconfigured to identify an injection site and/or guide placement of theinjection device. In some embodiments, the injection patch may be sizedand/or shaped for a particular body part. In the embodiment of FIG. 22,the injection patch 300 is a forehead patch. In the embodiment of FIG.23, the injection patch 400 is an eye patch configured for one or moreinjections near a user's eye. In alternative embodiments, the injectionpatch may be a neck patch, a scalp patch, or a combination thereof. Insome embodiments, an adhesive may be arranged on a contact surface ofthe injection patch for adhering the patch to a user's skin and anumbing agent may be provided on the contact surface. The injectionpatches 300/400 may include registration features 310/410 and holes320/420.

In general the injection templates or patches may have holes or markingscorresponding with injection sites on a body. In some embodiments, theinjection templates or patches may be shaped to correspond with aspecific location on the body and the holes or markings thus may alignwith injection sites at that specific location. The holes or markingsmay be provided so that they appears in the same location on theinjection template as positioned on the body as before positioning. Theholes or markings may be configured for receiving a needle of theinjection device.

In some embodiments, the cartridges in the kit may have varyingquantities of botulinum toxin. In some embodiments, the injectionlocations and cartridges may be color-coordinated or otherwiseidentified, such that a user may select an appropriate cartridge with anappropriate amount of botulinum toxin for an appropriate injectionlocation.

The holes 320/420 in the injection patch may be sized and configured toreceive the leading end of the cartridges or to permit the needle toextend therethrough to penetrate the skin. In some embodiments, theshroud around the needle on the cartridge may have a shape and/or sizematching that of the holes in the injection patch. As such, theplacement of the injection device with a loaded cartridge may allow forthe use of dexterity by the user to ascertain proper positioning of theinjection device.

In some embodiments, the holes 320/420 may instead comprise markingswhere the needle simply pierces the markings. This may be done, forexample, where the injection patch or template comprises a relativelyflimsy material.

The injection patch may be composed of any suitable material(s) such aspaper, plastic, fabric, and/or other suitable materials. The injectionpatch may generally have a contact surface or side configured to bearranged in contact with a user's skin. An adhesive component may bearranged on at least a portion of the contact surface. The adhesivecomponent may include a relatively mild glue, for example. In someembodiments, the adhesive component may include a silicone-basedadhesive, for example. The adhesive component may be arranged over allor a select portion of the contact surface of the patch.

In some embodiments, the injection patch may have a numbing agentarranged on at least a portion of the contact surface, so as to providea numbing effect to help reduce pain at the injection site. The numbingagent may include lidocaine or a similar anesthetic component in someembodiments. The numbing agent may include, for example, betweenapproximately 1% and 20% lidocaine in an aqueous base. Particularly, forexample, the numbing agent may include approximately 5% lidocaine in anaqueous base in some embodiments. In some embodiments, the numbing agentmay be combined with the adhesive element on the patch. In otherembodiments, the numbing agent may be arranged over a portion of thecontact surface of the patch, while the adhesive may be arranged over adifferent portion of the contact surface of the patch. In still otherembodiments, the adhesive component may be arranged over the numbingagent, for example. In some embodiments, the numbing agent may begin tonumb a user's skin upon contact.

In some embodiments, the injection patch may include a sponge-likematerial or other relatively flexible and/or porous material. Thesponge-like material may be configured to absorb or retain a quantity ofnumbing agent. In some embodiments, the contact surface of the patch mayinclude such material. For example, where the numbing agent is anaqueous lidocaine solution, the numbing agent may be arranged within thesponge-like material, and an adhesive may be arranged over thesponge-like material.

It may be appreciated that in some embodiments, an injection patch mayhave a buffer or a section of the patch that does not contain adhesiveor numbing agent. For example, where a patch is configured to bearranged near a user's eye, the patch may have a buffer zone orcomponent, such as a 2 millimeter zone or other appropriately sizedzone, arranged nearest the user's eye, so as to mitigate seepage of thenumbing agent and/or adhesive near the user's eye. In some embodiments,the buffer may include a portion of the sponge-like material describedabove.

In some embodiments, a covering, such as a paper or plastic basedcovering, may be arranged over the adhesive and/or numbing agent on thecontact surface of the patch. The covering may be configured to protectthe adhesive and/or numbing agent until use by a user. For example, thecovering may be a peelable paper based liner.

In some embodiments, one or more injection patches may be shaped, sized,and/or otherwise configured for use at a particular location on theuser's body. For example, FIGS. 22 and 23 illustrate examples of aforehead patch 300 and an eye patch 400. Additionally, in someembodiments, the injection patch may have one or more openings 320/420,such that the user may position the syringe needle and inject thebotulinum toxin solution through the patch. In this way, the one or moreopenings on the injection patch may operate as a guide to help usersplace the injections at the desired locations. As mentioned, theopenings may be sized and shaped to receive the leading end of acartridge, for example. In some embodiments, the injection patch may bepartially or entirely transparent. For example, the injection patch maybe transparent with the exception of colored rings around each injectionopening.

The forehead patch 300 may be configured to be arranged on a user'sforehead area, generally above the nose and between the eyes, so as totarget skin lines or wrinkles in this area. In some embodiments, theforehead patch may have one or more features to help a user position thepatch in the desired location on the user's skin. For example, as shownin FIG. 22, the forehead patch 300 may have a registration feature 310,which may be, for example, a peak configured such that a user mayposition the peak centrally between the user's eyes and directed at thebridge of the nose. Additionally or alternatively, the forehead patch300 may have one or more other registration features configured to helpa user register the patch with respect to the user's forehead, hairline,eyes, nose, eyebrows, or other facial features. FIG. 24 illustrates afront view of an injection patch 300 arranged on a user's forehead,according to one or more embodiments.

The forehead patch 300 may have one or more openings 320, as shown inFIG. 22. Each opening 320 may be arranged on the patch 300 so as toidentify a desired location for an injection. For example, as shown inFIG. 22, in some embodiments, the forehead patch 300 may include 5injection openings 320 configured to provide a guide for placinginjections at 5 locations along the user's forehead. In otherembodiments, the forehead patch 300 may include 1, 2, 3, 4, or any othersuitable number of injection openings 120. Each opening 320 maygenerally be large enough for a user to arrange the syringe through theopening, and additionally may be small enough so as to identify atargeted location for the injection. In some embodiments, the openings320 may be sized to receive the injection device. For example, theopenings 320 may be configured such that a user may insert an injectionend of the injection device through the opening in the patch. This mayhelp ensure that the injection is placed centrally within the opening320. The forehead patch 300 may generally be sized and shaped toaccommodate the desired number of injection openings and to be arrangedcomfortably on the user's skin in the desired location. In one or moreembodiments, the number of openings in the patch may correspond to thenumber of cells in the staging template holding the cartridges.

FIG. 25 illustrates a front view of an injection patch 400 arranged on auser's eye area, according to one or more embodiments. The eye patch 400may be configured to be arranged near a user's eye area, such asalongside a user's eye, so as to target skin lines or wrinkles in thisarea. In some embodiments, the eye patch 400 may have one or morefeatures to help a user position the patch in the desired location onthe user's skin. For example, as shown in FIG. 23, the eye patch 400 mayhave a registration feature 410, such as for example a tab configuredsuch that a user may position the tab proximate to the corner of theuser's eye. As shown for example in FIG. 25, the registration feature410 may be configured to be positioned at or near an outer corner of theuser's eye, so as to position the eye patch 400 in a desired location.In some embodiments, the registration feature 410 may be removable, suchthat a user may use the tab to accurately position the patch 400, andthen remove the tab for comfort and/or ease of injection. In otherembodiments, the eye patch 400 may include additional or alternativeregistration features to help a user register the eye patch with respectto the user's eye, eyebrow, or other facial features.

The eye patch 400 may have one or more openings 420, as shown in FIGS.23 and 25. Each opening 420 may be arranged on the patch 400 so as toidentify a desired location for an injection. For example, in someembodiments, the eye patch 400 may include 3 injection openings 420configured to provide a guide for placing injections at 3 locations nearthe user's eye. In other embodiments, the eye patch 400 may include 1,2, 4, or any other suitable number of injection openings 420. Eachopening 420 may generally be large enough for a user to arrange thesyringe through the opening, and additionally may be small enough so asto identify a targeted location for the injection. In some embodiments,the openings 420 may be sized to receive the injection device. Forexample, the openings 420 may be configured such that a user may insertan injection end of the injection device through the opening in thepatch 400. This may help ensure that the injection is placed centrallywithin the opening 420. The eye patch 400 may generally be sized andshaped to accommodate the desired number of injection openings 420 andto be arranged comfortably on the user's skin in the desired location.As with the forehead patch, in one or more embodiments, the number ofopenings in the patch 400 may correspond to the number of cells in thestaging tray or template holding the cartridges.

FIG. 26 illustrates a perspective view of an injection patch 300arranged on a user's forehead and an injection patch 400 arranged on auser's eye area, according to one or more embodiments.

The one or more injection openings 320, 420 on each patch 300, 400 maybe color coded or otherwise marked with an identifier. The color codingor other marking(s) of the injection openings may correspond with colorcoding or other identification of syringes or cartridges, as describedabove. That is, for example, where one or more cartridges or syringesare prefilled with quantities of botulinum toxin or botulinum toxinsolution, the cartridges or syringes may have a color or otheridentifier to indicate the quantity of solution within the syringe. Suchquantities may correspond with particular injection locations. Forexample, cartridges or syringes having 3 units of botulinum toxin orbotulinum toxin solution may have a green cap, ring, sticker, or othercomponent. Correspondingly, injection openings on the eye patch may beidentified with a green circle or other component, or the eye patchitself may be green or have a green marker. Similarly, cartridges orsyringes having 5 units of botulinum toxin or botulinum toxin solutionmay have a yellow cap, ring, sticker, or other component, and injectionopenings on the forehead patch may be identified with a yellow circle orother component. In some embodiments, an injection patch may haveinjection openings having different colors or other markings. Forexample, one patch may wrap around a the top and side of a user's eyeand may have openings configured for forehead injections and eyeinjections. This use of corresponding colors or other matchingidentifiers between injection openings and cartridges or syringes mayhelp a user to inject an appropriate amount of botulinum toxin orbotulinum toxin solution at an appropriate location on the user's body.In other embodiments, other quantities and/or identifiers may be used.

While a particular type of system and kit have been described herein,still other approaches to self-administered botulinum toxin or otherdrugs, medicines, or solutions may be provided. The below discussionincludes various other aspects of the system that may be in addition toor an alternative to the above described system.

In some embodiments, the kit may include a predetermined quantity ofbotulinum toxin. The toxin may be combined in a solution with one ormore additional components, such as saline, in some embodiments. Thebotulinum toxin, saline, and/or other components may be combined in anysuitable quantities and ratios. Where cartridges are not provided, forexample, the botulinum toxin may be arranged in a bottle or vial, suchas an injection vial having a rubberized opening configured to receive asyringe needle, or other container in some embodiments. In otherembodiments, the botulinum toxin solution may be arranged within one ormore syringes, as described below. In still other embodiments, the kitmay exclude the botulinum toxin, such that a user may be required toobtain the solution from a medical professional or other source.

The syringes mentioned may be a standard plunger and barrel syringehaving a hollow needle. In some embodiments, the syringe may have astandard barrel and/or needle size. In one or more embodiments, thesyringe and/or the above-described cartridges may include a barrel size,or chamber size as the case may be, of 0.3 mL, 0.5 mL, or 1.0 mL. Thebarrel of the syringe or the chamber of the cartridge may have graduated1-unit, 0.5-unit, 0.1 mL, or other suitable and/or standard interval.The needle in the syringe or the cartridge may have a gauge rangingbetween 28 and 31 gauge, and a length ranging between 4 mm and 12.7 mm(0.5 in) in some embodiments. In other embodiments, the syringe orcartridge may have any suitable and/or standard barrel size, needlegauge, and/or needle length. The syringe or cartridge may be sized andgenerally configured to inject a desired quantity of a botulinum toxinsolution. For example, the syringe may be configured to measure andinject between approximately 1 and 10 units of a botulinum toxinsolution. Particularly, the syringe or cartridge may be configured tomeasure and inject between 2 and 7.5 units of a botulinum toxinsolution. More particularly, the syringe or cartridge may be configuredto measure and inject between 3 and 5 units of a botulinum toxinsolution in some embodiments. In other embodiments, the syringe orcartridge may be configured to measure and inject any other suitablequantity of a botulinum toxin solution or another suitable component.

The syringe or cartridge may be configured for single use and thus maybe a disposable syringe or cartridge in some embodiments. In otherembodiments, the syringe or cartridge may be reusable. In someembodiments, the kit may include a plurality of syringes or cartridgeshaving one or more sizes. In some embodiments, the one or more syringesor cartridges may be pre-filled. That is, the kit may include one ormore syringes or cartridges pre-filled with a desired quantity ofbotulinum toxin or botulinum toxin solution. Multiple syringes orcartridges may have varying quantities of botulinum toxin or solution insome embodiments. For example, some syringes or cartridges may bepre-filled with 3 units of the toxin or solution, while other units maybe pre-filled with 5 units of the toxin or solution.

In some embodiments, one or more cartridges or syringes may beparticularly identified for a use. Particularly, cartridges or syringeshaving differing sizes and/or filled with differing botulinum toxin orbotulinum toxin solution quantities may be color-coded or otherwisecoded or marked to identify their suitability for different uses. Forexample, syringes or cartridges having 3 units of botulinum toxin orbotulinum toxin solution may be color-coded or otherwise coded or markedto identify their suitability for use around a user's eyes or eyelids,and syringes or cartridges having 5 units of botulinum toxin orbotulinum toxin solution may be color-coded or otherwise coded or markedto identify their suitability for use around a user's forehead area. Inone embodiment, syringes or cartridges may have a colored needle cap,plunger end cap, wrapper, ring, sticker, or other component foridentification.

In some embodiments, the kit may include an injection device configuredto assist with injection of the botulinum toxin. In some embodiments,the injection device may be an automatic injection device, such as anAUTOJECT device, configured to receive a standard syringe andautomatically push the plunger of the syringe to inject the botulinumtoxin into the user's muscle or other tissue. In some embodiments, theinjection device may be configured to receive a particular syringe size.In this way, the injection device may have an inner width or diameterconfigured to minimize movement of the syringe within the device. Insome embodiments, the injection device may have a ballpoint pen-likedesign. The injection device may have one or more ergonomic features insome embodiments. The injection device may be a reloadable device, suchthat the user may perform multiple injections with the device. In otherembodiments, the injection device may be a single-use device having, forexample, a pre-loaded syringe component. In some embodiments, theinjection device may be a spring activated device. For example, asyringe may be loaded within the injection device against a compressedor partially compressed spring. The spring may operate to push theplunger of the syringe so as to expel the botulinum toxin through theneedle of the syringe.

The injection device may generally be configured to help a user tosafely and effectively deliver an injection of botulinum toxin oranother component without, for example, injecting the needle too deepbeneath the user's skin. For example, where a user may be injectingbotulinum toxin around the eye area, the injection device may help toensure that the user does not inject the needle too deep around theeyeball or eye socket. The injection device may help to control thedirection and angle of the injection. Moreover, the injection devicemay, in some embodiments, conceal or partially conceal the syringeand/or needle before and/or during an injection. In this way, theinjection device may help calm users who may have needle phobias orother difficulties with needles or syringes.

A botulinum toxin self-administration kit or system may be available toa user for at-home use in some embodiments. In other embodiments, such akit or system may be available to a physician, nurse, or other medicalprofessional for in-clinic or other in-office use, for example. In someembodiments, the kit may be configured for a particular use. Forexample, some kits may be configured for use with particular areas ofthe body, such as the eye area, forehead area, neck, scalp, or acombination thereof. In this way, a kit may have one or more patches andone or more syringes, injection devices, and/or botulinum toxinquantities configured for use on the particular area of the body. Otherkits may include patches, syringes, injection devices, and/or botulinumtoxin quantities for multiple body areas. In some embodiments, kits mayhave other selectable or variable components or features. For example,some kits may have relatively higher or lower botulinum toxinquantities, number of injections, or patch sizes.

In some embodiments, the present disclosure relates to a method forself-administering a botulinum toxin injection. The method may includerequesting a self-administered botulinum toxin kit, selecting aninjection patch, positioning the injection patch on the body, selectinga cartridge, engaging the cartridge with the injection device, andinjecting the botulinum toxin.

In some embodiments, requesting a self-administered botulinum toxin kitmay include obtaining a prescription or medical professionalrecommendation for botulinum toxin injections. The kit may be requestedby a user or the user's medical professional in some embodiments. Thekit may be requested by any suitable means, such as through a website,application, email, mail, telephone call, or any other suitable means.As described above, in some embodiments, botulinum toxin kits may beconfigured for different types of uses or injections. In this way, auser may request a kit particular to the user's needs.

The method for self-administered botulinum toxin injection mayadditionally include selecting an injection patch. As described above,some injection patches may be configured for particular injection areasor areas of the body. For example, where a user desires to injectbotulinum toxin around the user's eye area(s) to target lines orwrinkles around the eye area, the user may select an injection patchparticularly configured for the eye area.

The user may position the injection patch on the body area that willreceive one or more injections. In some embodiments, the user may removea covering, such as a protective covering over a contact side of thepatch, before positioning the patch. Moreover, as described above,positioning the patch may include registering the injection patch with abody part or feature. For example, the user may align a registrationtab, peak, or other element with the user's eye, nose, brow, or otherbody part or facial feature. In some embodiments, the user mayoptionally remove the registration tab or other registration elementafter positioning the injection patch.

The user may select a cartridge for injecting the botulinum toxin. Insome embodiments, this may include selecting a prefilled cartridge froma staging tray, based on a desired quantity of botulinum toxin orbotulinum toxin solution or a location to be injected. For example, asdescribed above, the user may select a syringe having a color or otheridentifier matching that of a corresponding injection hole and/or patchcolor or identifier. In other embodiments, the user may select acartridge based on size or other factors such as its location in thestaging tray that corresponds to a location of an injection. In someembodiments, where a prefilled cartridge is not used, the user may drawa desired quantity of botulinum toxin or solution into the syringe.

The user engages a cartridge with the main body/handle. The user may usethe injection device with the cartridge or syringe to inject thebotulinum toxin into the user's muscle or other tissue at the desiredinjection site. This may include positioning the syringe and/orinjection device through an injection opening in the patch, pressing theinjection device against the skin to release a safety mechanism, andpressing the actuation button of the injection device to cause theinjection device to advance the needle into the skin followed byinjection of the botulinum toxin or other solution.

It is to be appreciated that, while a variety of embodiments have beendescribed herein, the various features from the different embodimentsmay be combined. For example, features from a first injection device, asdescribed herein, may be combinable with features of a second injectiondevice described herein.

As used herein, the terms “substantially” or “generally” refer to thecomplete or nearly complete extent or degree of an action,characteristic, property, state, structure, item, or result. Forexample, an object that is “substantially” or “generally” enclosed wouldmean that the object is either completely enclosed or nearly completelyenclosed. The exact allowable degree of deviation from absolutecompleteness may in some cases depend on the specific context. However,generally speaking, the nearness of completion will be so as to havegenerally the same overall result as if absolute and total completionwere obtained. The use of “substantially” or “generally” is equallyapplicable when used in a negative connotation to refer to the completeor near complete lack of an action, characteristic, property, state,structure, item, or result. For example, an element, combination,embodiment, or composition that is “substantially free of” or “generallyfree of” an element may still actually contain such element as long asthere is generally no significant effect thereof.

To aid the Patent Office and any readers of any patent issued on thisapplication in interpreting the claims appended hereto, applicants wishto note that they do not intend any of the appended claims or claimelements to invoke 35 U.S.C. § 112(f) unless the words “means for” or“step for” are explicitly used in the particular claim.

Additionally, as used herein, the phrase “at least one of [X] and [Y],”where X and Y are different components that may be included in anembodiment of the present disclosure, means that the embodiment couldinclude component X without component Y, the embodiment could includethe component Y without component X, or the embodiment could includeboth components X and Y. Similarly, when used with respect to three ormore components, such as “at least one of [X], [Y], and [Z],” the phrasemeans that the embodiment could include any one of the three or morecomponents, any combination or sub-combination of any of the components,or all of the components.

In the foregoing description various embodiments of the presentdisclosure have been presented for the purpose of illustration anddescription. They are not intended to be exhaustive or to limit theinvention to the precise form disclosed. Obvious modifications orvariations are possible in light of the above teachings. The variousembodiments were chosen and described to provide the best illustrationof the principals of the disclosure and their practical application, andto enable one of ordinary skill in the art to utilize the variousembodiments with various modifications as are suited to the particularuse contemplated. All such modifications and variations are within thescope of the present disclosure as determined by the appended claimswhen interpreted in accordance with the breadth they are fairly,legally, and equitably entitled.

What is claimed is:
 1. An injection device for injection of a fluid, theinjection device comprising: a body portion having a cartridge end and ahandle end, the body portion comprising: a main body; an injectionassembly extending through the main body to the cartridge end andeffecting insertion of a needle and ejection of the fluid; and anactuation button, wherein actuation of the actuation button leads toinsertion of the needle and dispensing of the fluid; and a cartridgeremovably couplable to the body portion at the cartridge end, thecartridge comprising; a syringe assembly including a drug chamber and apiston, wherein the drug chamber houses the fluid; the needle; and aneedle shield positioned over the needle; and a safety mechanismcomprising a body portion safety interlock and a cartridge safetyinterlock, wherein the cartridge safety interlock engages the bodyportion safety interlock such that the body portion safety interlockreleases the actuation button for actuation, wherein the safetymechanism is released upon depression of the needle shield such that theneedle may be inserted and the fluid dispensed.
 2. The injection deviceof claim 1, wherein the injection device has multi stage deploymentcomprising insertion of the needle and injection of the fluid.
 3. Theinjection device of claim 2, wherein the multi stage deployment isactivated by actuating the actuation button.
 4. The injection device ofclaim 1, wherein the injection assembly works with the piston of thecartridge to dispense the fluid.
 5. The injection device of claim 1,wherein the body portion further comprises a cocking assembly comprisinga cocking handle, an end cap, a cocking ring, and a snap ring, andwherein the cocking assembly is provided at the handle end of the bodyportion.
 6. The injection device of claim 1, wherein when the cartridgesafety interlock is in a used configuration, the needle shield is lockedin a forward position and the cartridge cannot be reused.
 7. Theinjection device of claim 1, wherein the injection assembly furthercomprises a needle insertion spring and a drug delivery spring.
 8. Theinjection device of claim 1, wherein the cartridge includes an extensionpiece and the body portion includes an opening piece, wherein theextension piece is received by the opening piece to removably couple thecartridge to the body portion.
 9. The injection device of claim 1,wherein the cartridge is predosed with a specific quantity of fluid. 10.The injection device of claim 1, wherein the injection device has multistage deployment comprising insertion of the needle and injection of thefluid, and wherein the multi stage deployment is triggered by actuationof the actuation button.
 11. An injection device for injection of afluid, the injection device comprising: a body portion having acartridge end and a handle end, the body portion comprising: aninjection assembly wherein the injection assembly effects insertion of aneedle and ejection of the fluid; and an actuation button whereinactuation of the actuation button leads to insertion of the needle anddispensing of the fluid; a cartridge removably couplable to the bodyportion at the cartridge end, the cartridge comprising; a syringeassembly including a drug chamber and a piston, wherein the drug chamberhouses the fluid; the needle; and a needle shield over the needle, theneedle shield having an initial position over the needle and a depressedposition; and a safety mechanism configured to prevent dispensing of afluid, the safety mechanism comprising a body portion safety interlockand a cartridge safety interlock, wherein the cartridge safety interlockengages the body portion safety interlock such that the body portionsafety interlock releases the actuation button for actuation, whereinthe safety mechanism is released upon proper positioning of theinjection device, wherein such release enables the needle to be insertedand the fluid to be dispensed.
 12. The injection device of claim 11,wherein proper positioning is achieved when the needle shield is in thedepressed position.
 13. The injection device of claim 11, wherein thedrug chamber is formed of glass and other portions of the cartridge areformed of plastic.
 14. The injection device of claim 12, wherein thesafety mechanism is reengaged when the needle shield returns to theinitial position.
 15. The injection device of claim 11, wherein the bodyportion safety interlock is an electrical switch.
 16. An injectiondevice for injection of a fluid, the injection device comprising: a bodyportion having a cartridge end and a handle end, the body portioncomprising: a main body; an injection assembly extending through themain body to the cartridge end and effecting insertion of a needle andejection of the fluid; and an actuation button, wherein actuation of theactuation button leads to insertion of the needle and dispensing of thefluid; and a cartridge removably couplable to the body portion at thecartridge end, the cartridge comprising; a syringe assembly including adrug chamber and a piston, wherein the drug chamber houses the fluid;the needle; and a needle shield positioned over the needle; and a safetymechanism comprising a body portion safety interlock and a cartridgesafety interlock, wherein the cartridge safety interlock comprises aslip ring having pins; wherein depression of the needle shield causesthe needle shield to press back the pins of the cartridge safetyinterlock wherein said pins engage and release the body portion safetyinterlock, which in turn allows the actuation button to be pressed toinject the fluid.